(Not Applicable)
Urinary incontinence is believed to affect 15% to 30% of noninstitutionalized persons over the age of 60, and more then 50% of elderly persons (over the age of 60) who reside in nursing homes.
The presently available modes of treatment for urinary incontinence fall into four general categories, namely: i) management apparatus, ii) behavioral, iii) pharmacologic, and iv) surgical.
The management apparatus modes of treatment generally comprise absorbent and/or catheter structures worn by a user to retain any urinary and/or fecal incontinence. In their simplest forms, such devices comprise diaper-like structures which must be periodically changed by the user. Although such management apparatus has proven generally effective in masking the results of incontinence, they are uncomfortable to wear, difficult to change, and oftentimes fail during use thereby embarrassing the user.
The use of behavioral training as a treatment for urinary and/or fecal incontinence can involve numerous behavioral techniques including; bladder retraining (e.g., voiding on a timed schedule), and/or the performance of exercises (e.g., Kegel exercises) to strengthen and retrain a group of muscles collectively known as the xe2x80x9cpelvic floor muscles.xe2x80x9d As an adjunct to these behavioral training techniques, various intravaginal and/or intra-anal devices may be utilized to facilitate the performance of such pelvic muscle training exercises. Such intravaginal and/or intra-anal devices have included weighted apparatus such as intravaginal cones. Exemplary of such prior art include weighted cone devices such as the xe2x80x9cFEMINAxe2x80x9d cone manufactured by Dacomed Corporation, 1701 East 79th Street, Minneapolis, Minn., 55425. Other types of prior art devices include electromyographic (EMG) transducers or sensors which are insertable into or placed just outside of the vagina and/or anus to obtain EMG data indicative of baseline pelvic floor muscle tone and/or contraction(s) of the pelvic floor muscles during the performance of specific muscle contraction exercises. Such EMG data may be usable for diagnostic purposes as well as for monitoring the performance and/or effect of muscle training exercises. Some EMG devices have included means for providing visual or auditory feedback to assist the patient in the performance of pelvic floor muscle exercises (e.g., Myoexorciser III, available from Verimed 1401 East Broward Boulevard, Suite 200, Fort Lauderdale, Fla. 33301 and the PRS 8900 Office System made by Incare Medical Products, Libertyville, Ill. 60048.
Additionally, the prior art has included at least one transvaginal electrical stimulation device which is operative to deliver periodic or timed electrical stimulation to the pelvic floor muscles and nerves. Such electrical stimulation causes involuntary contraction of the pelvic floor muscles and may serve as an adjunct to the performance of volitional exercise and/or other behavioral training techniques (e.g., Microgyn II Stimulation Device, InCare Medical Products, Division of Hollister Incorporated, 2000 Hollister Drive, LibertyVille, Ill., 60048 and also the Innova Feminine Incontinence Treatment System available from EMPI, Inc., 1275 Grey Fox Road, St. Paul, Minn. 55112).
Although some of or all of the above-described devices and systems for exercise and/or training of the pelvic floor muscles may be effective in the treatment of urinary incontinence, there remains a need for the development of improved devices and systems which are capable of strengthening and training the pelvic floor muscles in minimal time, with minimal assistance from physicians or other health care professionals as well as a system which serves to remind a user to perform muscle exercises and to provide proprioceptive input to assist the user in exercising and strengthening desired muscles.
The prior art pharmacologic treatment of urinary incontinence typically involves the long term administration of drugs. Such pharmacologic treatment may result in drug-related side effects. Also, the efficacy of such pharmacologic treatment is frequently limited and largely dependant upon the patient""s ability or willingness to comply with the prescribed drug dosage schedule.
The prior art surgical modes of treatment of urinary incontinence typically involves the performance of one or more major surgical procedures under anesthesia. These major surgical procedures can be associated with significant risks and may sometimes result in post-surgical failure, infections, or other complications. Also, these surgical procedures typically result in significant expense to the patient and/or the patient""s third party insurer.
As such, there exists a substantial need in the art for an incontinence treatment system and methodology which reduces or eliminates the need for prior art management apparatus and/or surgical, treatments, reduces the use of long-term drug administration, accentuates muscle strengthening and training while reminding a patient to conduct muscle strengthening exercise, as well as provide a proprioceptive input to assist the patient in contracting the appropriate muscles and/or muscle groups necessary for the effective treatment of incontinence.
In addition to the need for an incontinence treatment system as discussed above, there is a further need in the art for a system that can further promote genitourinary health. In this respect, and separate and apart from the treatment of incontinence, there is currently lacking any apparatus or system that is known to facilitate genitourinary health via the deployment of a variety of therapeutic modalities, and in particular magnetic therapy and vibratory stimulation.
With respect to the former, it is well-known in the art to use magnets to therapeutically relieve pain and discomfort. In this regard, the use of magnets is reportedly successful in treating a wide variety of conditions, including arthritis, rheumatism, fibromyalgia, back pain, headaches, muscle strains and sprains, joint pain, tendinitis and shoulder pain, among many others.
To produce the desired therapeutic benefit, it is presently believed that exposure to bio-magnetic negative poles, or north-poles, has the ability to relieve pain, reduce swelling, promote tissue alkalinization, and increase tissue oxygenation. Exposure to south or positive-poles, in contrast, is believed to increase swelling, promote anxiety and other adverse side-effects. As such, current magnetic therapy dictates surrounding all or a portion of the body in close proximity to the north or negative-poles of a plurality of magnets.
To date, however, there is currently lacking any type of apparatus or system for deploying magnetic therapy to the pelvic region of an individual such that the muscles, organs and anatomic structures in and around such area, such as the small and large intestines, rectum, lower urinary tract, sexual or reproductive organs, hip/lower back and other neighboring joints or bones, can receive the benefits thereby. While new medical devices, and in particular the NebControl(trademark) Pelvic Floor Therapy System, produced by Neotonus, Inc., 810A Franklin Court, Marietta, Ga., 30067, USA, are now available which impart pulses of magnetic fields to the pelvic floor to treat incontinence, such apparatus and method utilize a sophisticated and expensive therapy chair. Such therapy chair produces and directs strong pulse magnetic fields of sufficient magnitude to cause nerve impulses situated in the pelvic floor, which innervate the muscles responsible for continence. The fields pass through the targeted treatment area to deliver the therapeutic action. Unfortunately, such device, in addition to being costly, further requires medical supervision and the deployment of medical equipment that must necessarily be maintained at a medical facility.
With respect to vibratory stimulation as a means for promoting genitourinary health, it is well-known that the same can increase blood flow to the genitourinary region and can improve sexual well-being via stimulation of the sexual organs. Presently lacking in the art though, is a system or apparatus for imparting perceptible input to the sexual/reproductive organs in the form of vibratory stimulation that, in addition to applications for treating incontinence, can further serve to stimulate and create feelings of sexual well-being and gratification. In this regard, there is specifically lacking in the art any type of system or apparatus that can be selectively controlled to impart a degree of stimulation of sufficient magnitude and for sufficient duration to induce orgasm.
There is likewise lacking in the art any type of device for imparting cutaneous stimulation to the pelvic region as a means of pain management. In this respect, there is presently not available any type of apparatus or system that selectively imparts stimulus to the pelvic region of a patient which, in turn, can substantially decrease or inhibit the transmission of impulses from small diameter afferent peripheral nerve fibers to the spinal cord cells to thus modulate pain transmission. In this regard, there is lacking any type of system that generates cutaneous stimuli that is specifically applied to the pelvic region to illicit activity from large-diameter afferent nerve fibers to consequently inhibit transmission of nociceptive signals generated by excitatory activity in small-diameter fibers converging in the superficial laminae of the spinal cord dorsal horn (i.e., the substantia gelatinosa) consistent with the gate-control theory of pain.
In accordance with the present invention, there is provided an external exercising signaling device which is positionable upon the crotch of a patient to identify target muscle groups responsible for fecal and/or urinary continence, and provide a signal to the patient to perform the appropriate muscle strengthening exercises therefor. According to a preferred embodiment, the device comprises a saddle member having a signaling device housed therein, the latter being designed and configured to impart a perceptible stimulus against a portion of the crotch of the individual upon which the saddle member is positioned to thus remind the patient to perform the desired pelvic muscles strengthening exercises.
The signaling device may preferably comprise a pressure-exerting device, heater, or any other like device capable of generating a perceptible stimulus. In an alternative preferred embodiment, the signaling device may comprise a stimulator that is configured to impart stimulation to the sexual organs to improve sexual well-being through pleasure, as part of its ability to generate a perceptible stimulus. A powersource, i.e., a battery, coupled to the signaling device and preferably housed within the saddle member is provided to drive the signaling device. Additionally, a timer apparatus may be mounted on or within the device to trigger and control the timing, duration, repetitions, and frequency of perceptible stimulus signals generated by the signaling device on a predetermined time schedule.
Still further in accordance with the invention, a remote controlled triggering device may be used in addition to, or in place of, a timer or other control apparatus mounted or housed within the saddle member. Such remote control apparatus may be utilized to trigger, control and/or schedule all operational parameters of stimulus produced by the signaling device from a remote location.
In addition, or as an alternative to treating urinary incontinence, the present invention may further be utilized to impart magnetic therapy to the pelvic/genitourinary region of an individual. In this regard, the saddle member may be provided with one or more magnetic elements positioned therewith or thereupon such that the negative or north pole thereof is situation in close proximity to the pelvic/genitourinary regions of the body for prolonged periods of time.
The present invention can additionally be utilized for pain management by generating a cutaneous stimuli to modulate the transmission of pain. In this regard, the exercise-stimulation device of the present invention is adaptable to impart stimuli to the nerves of the pelvic floor which, as a consequence, can selectively and substantially diminish nociceptive neural transmissions.
Still further in accordance with the invention, there is provided a method of treating urinary and/or fecal incontinence in a patient. In general, the method comprises the steps of compressively positioning an external exercising device of the forgoing character upon the crotch of a patient, and utilizing the device to intermittently deliver stretch, resistance, vibration, pressure or heat stimuli against the crotch and/or adjacent muscles thereabout to facilitate the performance of pelvic muscle strengthening exercises by the patient upon whom the device is positioned.
There is likewise provided a method of managing pain in a patient. Such method preferably comprises the steps of compressively positioning the external stimulation device discussed above and utilizing the device to impart a cutaneous stimulus of sufficient nature to the pelvic region to modulate pain transmission by inhibiting nociceptive neural transmissions.